Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: ResearchStudy Classifier Code System

Page standards status: Informative

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="419455"/>
  <meta>
    <versionId value="4"/>
    <lastUpdated value="2025-12-15T16:50:42.236Z"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 419455</b></p><a name="419455"> </a><a name="hc419455"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 4; Last updated: 2025-12-15 16:50:42+0000</p></div><p>This  code system <code>https://fevir.net/resources/CodeSystem/419455</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">fda-regulated-drug<a name="419455-fda-regulated-drug"> </a></td><td>FDA regulated drug</td><td>A medication regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style="white-space:nowrap">fda-regulated-device<a name="419455-fda-regulated-device"> </a></td><td>FDA regulated device</td><td>A medical device regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style="white-space:nowrap">irb-exempt<a name="419455-irb-exempt"> </a></td><td>IRB-exempt</td><td>Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).</td></tr><tr><td style="white-space:nowrap">mpg-paragraph-23b<a name="419455-mpg-paragraph-23b"> </a></td><td>MPG Paragraph 23b</td><td>Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).</td></tr><tr><td style="white-space:nowrap">includes-females<a name="419455-includes-females"> </a></td><td>Includes female subjects</td><td>Includes female subjects</td></tr><tr><td style="white-space:nowrap">does-not-include-females<a name="419455-does-not-include-females"> </a></td><td>Does not include female subjects</td><td>Does not include female subjects</td></tr><tr><td style="white-space:nowrap">includes-males<a name="419455-includes-males"> </a></td><td>Includes male subjects</td><td>Includes male subjects</td></tr><tr><td style="white-space:nowrap">does-not-include-males<a name="419455-does-not-include-males"> </a></td><td>Does not include male subjects</td><td>Does not include male subjects</td></tr><tr><td style="white-space:nowrap">includes-vulnerable-population<a name="419455-includes-vulnerable-population"> </a></td><td>Includes vulnerable populations</td><td>Includes vulnerable populations</td></tr><tr><td style="white-space:nowrap">does-not-include-vulnerable-population<a name="419455-does-not-include-vulnerable-population"> </a></td><td>Does not include vulnerable populations</td><td>Does not include vulnerable populations</td></tr><tr><td style="white-space:nowrap">includes-healthy-volunteers<a name="419455-includes-healthy-volunteers"> </a></td><td>Includes healthy volunteers</td><td>Includes healthy volunteers</td></tr><tr><td style="white-space:nowrap">does-not-include-healthy-volunteers<a name="419455-does-not-include-healthy-volunteers"> </a></td><td>Does not include healthy volunteers</td><td>Does not include healthy volunteers</td></tr></table></div>
  </text>
  <extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as">
    <valueMarkdown
                   value="ResearchStudy Classifier Code System [Database Entry: FHIR CodeSystem Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 419455. Revised 2025-12-15. Available at: https://fevir.net/resources/CodeSystem/419455. Computable resource at: https://fevir.net/resources/CodeSystem/419455#json."/>
  </extension>
  <url value="https://fevir.net/resources/CodeSystem/419455"/>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net/FOI"/>
    <value value="419455"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.16.8"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name value="ResearchStudyClassifierCodeSystem"/>
  <title value="ResearchStudy Classifier Code System"/>
  <status value="active"/>
  <date value="2025-12-18T14:27:29+00:00"/>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <description
               value="This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <author>
    <name value="Brian S. Alper, MD, MSPH"/>
  </author>
  <valueSet value="https://fevir.net/resources/ValueSet/419456"/>
  <content value="complete"/>
  <concept>
    <code value="fda-regulated-drug"/>
    <display value="FDA regulated drug"/>
    <definition
                value="A medication regulated by the U.S. Food and Drug Administration."/>
  </concept>
  <concept>
    <code value="fda-regulated-device"/>
    <display value="FDA regulated device"/>
    <definition
                value="A medical device regulated by the U.S. Food and Drug Administration."/>
  </concept>
  <concept>
    <code value="irb-exempt"/>
    <display value="IRB-exempt"/>
    <definition
                value="Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."/>
  </concept>
  <concept>
    <code value="mpg-paragraph-23b"/>
    <display value="MPG Paragraph 23b"/>
    <definition
                value="Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."/>
  </concept>
  <concept>
    <code value="includes-females"/>
    <display value="Includes female subjects"/>
    <definition value="Includes female subjects"/>
  </concept>
  <concept>
    <code value="does-not-include-females"/>
    <display value="Does not include female subjects"/>
    <definition value="Does not include female subjects"/>
  </concept>
  <concept>
    <code value="includes-males"/>
    <display value="Includes male subjects"/>
    <definition value="Includes male subjects"/>
  </concept>
  <concept>
    <code value="does-not-include-males"/>
    <display value="Does not include male subjects"/>
    <definition value="Does not include male subjects"/>
  </concept>
  <concept>
    <code value="includes-vulnerable-population"/>
    <display value="Includes vulnerable populations"/>
    <definition value="Includes vulnerable populations"/>
  </concept>
  <concept>
    <code value="does-not-include-vulnerable-population"/>
    <display value="Does not include vulnerable populations"/>
    <definition value="Does not include vulnerable populations"/>
  </concept>
  <concept>
    <code value="includes-healthy-volunteers"/>
    <display value="Includes healthy volunteers"/>
    <definition value="Includes healthy volunteers"/>
  </concept>
  <concept>
    <code value="does-not-include-healthy-volunteers"/>
    <display value="Does not include healthy volunteers"/>
    <definition value="Does not include healthy volunteers"/>
  </concept>
</CodeSystem>